Not applicable
This invention relates to ultrasonic medical imaging systems, and more particularly pertains to probes and scanning devices used in combination and in conjunction with ultrasonic medical imaging equipment, to provide a better focusing upon the potential site of disease at particular locations in the body, and more specifically the prostate, and in addition, provides a means for guiding the insertion and implantation of the biopsy needle or other treatment devices into a precise location, during medical treatment.
Ultrasound has become an important diagnostic tool for the medical professionals. Generally, ultrasound scanning means can be categorized as either a xe2x80x9ccavitalxe2x80x9d imaging device, or a xe2x80x9cbodyxe2x80x9d imaging device. The cavital imaging devices, often referred to as xe2x80x9cprobesxe2x80x9d, are usually of the type that are inserted into a cavity of the patient to image organs therein or those arranged juxtapose or adjacent to the cavity, to provide for a precise picture of the surrounding area. Cavital probes are often specifically designed for the configuration of the cavity to be imaged. Cavital probes include the type that provide transrectal imagining, such as for use for the detection of prostate cancer, and rectal cancer, in addition to transvaginal probes. In addition, transesophagual probes also provide for imaging.
Ultrasound works by using a transducer to generate a narrow pulse of sound, which travels through the surrounding tissue. The pulse of sound is then reflected back to and captured by the transducer, with the density and distance of tissue affecting how the signal is reflected. Currently two main types of transrectal cavital probes are in use: a bi-plane mechanical probe and a bi-plane solid-state probe. The standard mechanical probe contains one or more transducers that are mounted inside the hollow casing at the tip of the probe. The transducer(s) either pivot or rotate quickly within the tip (approximately five to ten times per second) to generate and receive pulses at multiple points. Depending upon the movement used, a pie-shaped cross sectional image generated either inline with the probe tip (longitudinally) or perpendicular thereto (transversely). This dual axes image capability is referred to as bi-plane imagining. The solid-state probe operates in a similar manner, except that the single transducer is replaced with inline columns of very small transducers. The transverse columns are wrapped around a small portion of the diameter of the probe and longitudinal columns runs approximately sixty millimeters along the length of the probe. Instead of pivoting a transducer, the multiple transducers of each column are sequentially pulsed to create a cross sectional image. Therefore, like the mechanical probe, the solid-state probe is able to generate dual axis, bi-plane images.
Ultrasound has become the primary method of imaging the prostate and is an integral component in a number of widely used prostate cancer treatment procedures. A rectally inserted ultrasound probe of either type, in conjunction with imaging software, allows the doctor to display a two dimensional image of the prostate on the longitudinal plane, and a two dimensional image on the transverse plane. The doctor can view these images to evaluate the prostate for cancer, and if necessary prescribe a treatment regimen. Both types of current probes must be mounted on a large stand, referred to as a xe2x80x9cstepper and stabilizerxe2x80x9d. The stepper and stabilizer are used to maintain the stability of the probe within the rectum and also allow it to be precisely moved in and out and to be rotated by the use of hand operated controls. The in and out movement is typically performed in five millimeter increments to facilitate the collection of eight to ten 2D transverse images that a computer then assembles to create a rough 3-dimensional approximation of the 3D volume of the prostate. The xe2x80x9cfree handxe2x80x9d/diagnostic rotational movement is used to view the prostate, needles and other treatment devices in the longitudinal mode. Conventional probes, in combination with the steppers, have multiple operational problems and limitations.
Further, a very popular treatment for prostate cancer is brachytherapy, in which a series of tiny radioactive seeds are embedded in the prostate in an attempt to destroy any present carcinoma. A rectally inserted ultrasound probe is used to guide the insertion of needles through the skin and into the prostate as part of this treatment. Regardless of the treatment option utilized, a transrectal ultrasound probe is needed to help diagnose, plan, and most often guide, the treatment procedure.
Existing probe designs suffer from a number of problems and deficiencies. Moving the probe in and out of the rectum or vagina can be extremely uncomfortable for the patient, and it also causes the prostate, needles, and radioactive seeds and other diagnostic and treatment devices to move, therefore constantly changing their position during diagnostic and the treatment methods. All of the probe movement is hand-initiated and powered by the physician. As a result, the process of taking the multiple images is extremely slow, increasing the length of the time the probe must be in the patient""s rectum and further increasing the time the doctor spends on the procedure. Also, the readings and scans may be inaccurate due to the manual participation manually record location. Also standard steppers usual only move in large, five millimeter increments more or less, limiting the number of cross sections obtained and limiting the information available to the physician after the probe is removed from the patient. Further, because of the need to move the whole probe, the stepper must be very steady. Consequently, steppers are very large and expensive devices, substantially increasing the cost of an ultrasound treatment system. As such, the use of transrectal imaging has been limited and has not fully reached its potential as a preferred diagnostic tool.
Various prior art imaging systems have been available in the art, as can be seen from a number of publications. For example, the patent to Fenster, et al, U.S. Pat. No. 5,964,707, shows a 3-dimensional imaging system. While this particular 3-dimensional ultrasound imaging system may provide for an inputting of ultrasound signals from a transducer, it essentially utilizes the ultrasound probe to provide for linear scanning, wherein successive 2-dimensional images of the target volume are detected, and then digitized, to obtain other images. Another patent to Fenster, U.S. Pat. No. 5,842,473, also upon a 3-dimensional imaging system, operates on the same principle.
The patent to Wilson, U.S. Pat. No. 5,611,343, discloses a high resolution 3-dimensional ultrasound imaging system. It provides ultrasound imaging for generating high resolution, 3-dimensional images of the body for medical imaging purposes. The system includes a housing and a rotatable disc, at one end of its probe, to obtain its ultrasound images.
The patent to Herries, U.S. Pat. No. 5,070,879, shows another ultrasound imaging method and apparatus.
The patent to Frazien, U.S. Pat. No. 5,394,878, discloses a method for 2-dimensional real time color Doppler ultrasound imaging of bodily structures through the gastrointestinal wall.
The United States patent to Wollschlager, et al, U.S. Pat. No. 5,105,819, shows an ultrasound endoscope device.
The patent to Saito, et al, U.S. Pat. No. 5,054,491, shows another ultrasonic endoscope apparatus.
The United States patent to Keen, et al, U.S. Pat. No. 5,931,788, discloses the method and apparatus for imaging internal organs and vascular structures through the gastrointestinal wall.
The patent to Hossack, U.S. Pat. No. 5,769,079, discloses the method and apparatus for determining quantitative measures of flow parameters.
The United States patent to Oaks, et al, U.S. Pat. No. 5,050,610, explains the transesophageal ultrasonic scan head.
The United States patent to Angelsen, U.S. Pat. No. 4,757,818, shows an ultrasonic transducer probe with linear motion drive mechanism. This particular patent appears to be more related to the specific type of motor means that are used to drive its probe in a linear motion.
The patent to Goldstein, U.S. Pat. No. 4,819,650, shows an ultrasound assembly comprised of a dual transducer probe, and a hollow casing. The casing acts as a guide to allow the probe to be maintained in one of two positions, so as to facilitate the positional registration of two separate transducers or arrays of transducers. Goldstein does not disclose a means for longitudinally positioning a transducer within the body of a probe, nor does it facilitate the image plane movements normally obtained by a standard probe when used in a stepping device.
The patent to Dow, et al, U.S. Pat. No. 4,841,979, shows an ultrasonic probe with a single transducer. The transducer is mounted on a pivoting platform which can also be rotated. This patent does not disclose a means of longitudinally positioning a transducer within the body of a probe, nor does it facilitate the image plane movements normally obtained by a standard probe when used in a stepping device.
The patent to Blumenthal, U.S. Pat. No. 5,048,529, shows an ultrasonic probe with a single transducer. The transducer is mounted on a pivoting platform. A pulley arrangement and flexible belt are used to cause the transducer platform to pivot so as to be able to vary the pivot arc distance. This patent does not disclose a means of longitudinally positioning a transducer within the body of a probe, nor does it facilitate the image plane movements normally obtained by a standard probe when used in a stepping device.
The patent to Bradley, U.S. Pat. No. 5,070,879, shows an ultrasound imaging apparatus using a longitudinal array of multiple transducers. The phased array is oscillated along the axis of the probe to generate transverse images. This patent does not disclose a means of longitudinally positioning a transducer within the body of a probe, nor does it facilitate the image plane movements normally obtained by a standard probe when used in a stepping device.
The patent to Takano, U.S. Pat. No. 5,090,414, shows an intercavity ultrasound probe. This is a probe of the mechanical scan type. As noted, this device includes a transducer element that locates at a distal end of the body, it includes a stab needle guide for guiding a stab needle and means for transmitting a torque from the driving source to the rotating shaft.
The patent to Pini, No. U.S. Pat. No. 5,159,931, shows an intra-cavity probe with a single transducer. The transducer is maintained on a platform which can be rotated containing a transducer which can be pivoted. This patent does not disclose a means of longitudinally positioning a transducer within the body of a probe, nor does it facilitate the image plane movements normally obtained by a standard probe when used in a stepping device.
Another patent to Takano, U.S. Pat. No. 5,170,793, shows an ultrasonic probe assembly with a single transducer for use in blood vessels. This patent shows mean for rotating the transducer within the tip of the probe, even if the probe body has been bent. This patent, though, does not disclose a means for providing longitudinal positioning of a transducer within the body of the probe, nor does it facilitate the image plane movements normally obtained by a standard probe when used in a stepping device.
The patent to Solomon, et al, U.S. Pat. No. 5,181,514, shows an ultrasonic probe for use in the esophagus. This device contains a motor which can rotationally turn an array of transducers to generate moveable scan planes. This device also shows means for positioning of the probe to provide feedback on the location of the probe. But, the patent does not disclose a means of longitudinally positioning a transducer within the body of a probe, nor does it facilitate the image plane movements normally obtained by a standard probe when used in a stepping device.
The patent to Webler, et al, U.S. Pat. No. 5,361,768, shows a longitudinal positioning translator for use with an ultrasound probe. The positioning translator physically moves the ultrasound probe within a body vessel. This patent does not disclose a means for longitudinally positioning a transducer within the probe body.
The patent to Okunuki, et al, U.S. Pat. No. 5,460,179, shows an ultrasound body scanner utilizing an array of transducers. The transducers are arranged linearly on a transducer unit within the hollow casing of the scanner. The transducer unit may be pivoted within the hollow body of the scanner, such that the image plane of the transducers is swung back and forth.
The patent to Schmulewitz, U.S. Pat. No. 5,474,072, shows methods and apparatus for performing sonomammography. The apparatus of this device combines ultrasonic scanning, affixed to a moveable carriage, and also mammography imaging means.
Another patent to Webler, U.S. Pat. No. 5,592,942, shows an automated longitudinal position translator for ultrasonic imaging probes, and methods of using the same. The positioning translator physically moves the ultrasonic probe within a blood vessel.
The patent to Moore, U.S. Pat. No. 6,004,271, discloses a combined motor drive and automated longitudinal position translator for ultrasonic imaging system. This discloses a vascular ultrasound imaging system with automated longitudinal position translator. A catheter containing the ultrasonic scanner is inserted into the vein within a catheter. Once a catheter is correctly positioned within a vein, the ultrasound scanner may be drawn back out of the catheter to affect a scanning of a portion of the vein.
Finally, the patent to Lin, et al, U.S. Pat. No. 6,200,269, shows a forward scanning ultrasound catheter probe. The transducer is maintained on a platform at the distal end of the probe, the platform being pivoted via a piezoelectric drive to create a scanning plane.
This invention relates primarily to scanning technology, and more particularly pertains to an ultrasonic medical imaging system that provides for the detection and location of disease, such as cancer, furnishes means for providing a full image of the scanned areas, and for precise locating of medical instrumentation used in the treatment and detection of such disease.
Generally, the instrument of this invention, comprising basically a scanning probe, and the supporting instrumentation that is used in conjunction therewith, provides a scanning probe, normally one that will sit upon a stand, within a cradle, but principally provides support for the probe of this invention. The purpose of the probe is to emit ultrasonic pulses, so that an accurate image of tissue or the prostate, when that is what is being observed, to obtain a thorough detection where a carcinoma may be located. The probe of this device, which emits the ultrasonic pulses, incorporates a series of a motor or motors, rearwardly of the ultrasonic probe, so that the means that emits the ultrasonic pulse can not only be rotated, or pivoted, to any degree, even up to 360 degrees, to provide a 2-dimensional image at the precise plane of the ultrasound, but likewise, the probe can be longitudinally reciprocated, in order to furnish the actual, not computer interpolated, 3-dimensional image, required and desired, to provide for the precise detecting and treatment of the diseased organ. A first motor or other means provides for the pivotal or revolutionary motion to the ultrasound emitter, while the second motor or other means furnishes its longitudinal displacement, as required for actual 3-dimensional imaging.
A first motor means turns an initial or outer shaft, while the second motor means turns an inner shaft, concentrically located within the outer shaft. The turning of an inner shaft provides for rotating of a belt or belts, while the turning of the outer shaft provides for a rotation of the probe carriage assembly, so that a complete 360xc2x0 image may be obtained, when the probe is inserted, as for example, within a rectum, to obtain an accurate image of the prostate, during detection, and also while treatment is being performed.
A belt means included within the probe, and which is subject to movement of the outer shaft, shifts the ultrasound unit longitudinally, while an internal belt(s), and all of its associated operating mechanisms, are revolved to provide for the 360xc2x0 scan by the ultrasound. The ultrasound transducer is associated with the mechanism, and it is shifted by means of the motor, belts, and other components during their functionality, to provide for these identified movements, along the various axes, to furnish the ultrasound scanning of the surrounding anatomy, and to achieve an accurate picture of the organ being observed or treated.
Accordingly, an object of the present invention is to provide a cavital or body scanning probe of mechanical design which facilitates the use of the ultrasound in a range of diagnostic and treatment uses. An advantage of the present invention is the structure of a device which allows the transducer or transducers to move reciprocally, in and out longitudinally, within the hollow cavity of the scanning means, while at the same time obtaining its simultaneously rotating or pivoting, allowing the transverse or longitudinal images to also move in and out, and rotate, thereby allowing multiple transverse and longitudinal images to be generated without requiring the probe body to be physically moved itself. This results in substantially less discomfort for the individual being scanned and treated. The invention is able to capture a significantly greater amount of data, which facilitates the accurate and proper treatment such as brachytherapy, and allows the doctor or technician, or even the treatment planning software or other remote means, significantly greater control of the image plane, which is able to generate a full, volumetric genuine 3-dimensional scan, of the surrounding anatomy, being observed, for any detected disease, and to be treated.
Another object of this invention is to provide a scanning probe that is a rather compact and fully encased mechanism, but yet provides for 3-dimensional scanning and movement of its internal operating components horizontally, transversely, and longitudinally, to furnish a volumetric dimensional actual scan of the body or parts thereof.
Still another object of this invention is to provide a scanning probe that may be inserted, only once, and then rendered fully operative to provide for its precise scanning, without further inconvenience or pain to the patient.
Still another benefit of this invention is the use of miniaturized motors, and other components, encased within a scanning probe, and which furnish all of the movements required to provide a 3-dimensional scan of the surrounding anatomy.
Still a further object of this invention is to provide a volumetric 3-dimensional scanning probe that may be used in conjunction with medical treatment instrumentation, so as to allow the physician to be extremely precise and accurate in the treatment of the patient, such as when, for example, radioisotopes are added to the prostate, or contiguous anatomy, for the treatment of cancer, or the like.
Still another object of this invention is to provide a scanning probe that facilitates the image plane movements normally obtained by a standard probe while used in a stepping device.
A further object of this invention is to provide a scanning probe that may scan various portions of the body
A further object of this invention is to provide a body scanning device which substantially lessens the vibrations generated through the use of previous type scanning mechanisms, and which can hinder ultrasonic imaging and cause patient discomfort.
Yet another object of this invention is to provide a form of pulley/sled design for a probe and which provides for a scanning mechanism which can operate in a fluid filled probe tip without changing the volume of the fluid filled tip cavity, negating the need for a fluid filled tip volume compensation means.
These and other objects may become more apparent to those skilled the art upon review of the invention as provided herein, and upon undertaking a study of the description of its preferred embodiment, in light of the drawings.